EP3085385A4 - Pharmaceutical composition comprising adalimumab - Google Patents

Pharmaceutical composition comprising adalimumab Download PDF

Info

Publication number
EP3085385A4
EP3085385A4 EP14871536.0A EP14871536A EP3085385A4 EP 3085385 A4 EP3085385 A4 EP 3085385A4 EP 14871536 A EP14871536 A EP 14871536A EP 3085385 A4 EP3085385 A4 EP 3085385A4
Authority
EP
European Patent Office
Prior art keywords
adalimumab
pharmaceutical composition
pharmaceutical
composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP14871536.0A
Other languages
German (de)
French (fr)
Other versions
EP3085385A1 (en
EP3085385B1 (en
Inventor
Weijie FANG
Haibin Wang
Minhong QIU
Hongjian ZHENG
Yuebin YING
Hua Bai
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hisun Biopharmaceutical Co Ltd
Original Assignee
Zhejiang Hisun Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zhejiang Hisun Pharmaceutical Co Ltd filed Critical Zhejiang Hisun Pharmaceutical Co Ltd
Publication of EP3085385A1 publication Critical patent/EP3085385A1/en
Publication of EP3085385A4 publication Critical patent/EP3085385A4/en
Application granted granted Critical
Publication of EP3085385B1 publication Critical patent/EP3085385B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pain & Pain Management (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP14871536.0A 2013-12-16 2014-12-12 Pharmaceutical composition comprising adalimumab Active EP3085385B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201310693338.5A CN104707146B (en) 2013-12-16 2013-12-16 A kind of pharmaceutical composition containing adalimumab
PCT/CN2014/093722 WO2015090162A1 (en) 2013-12-16 2014-12-12 Pharmaceutical composition comprising adalimumab

Publications (3)

Publication Number Publication Date
EP3085385A1 EP3085385A1 (en) 2016-10-26
EP3085385A4 true EP3085385A4 (en) 2017-06-28
EP3085385B1 EP3085385B1 (en) 2021-08-25

Family

ID=53402094

Family Applications (1)

Application Number Title Priority Date Filing Date
EP14871536.0A Active EP3085385B1 (en) 2013-12-16 2014-12-12 Pharmaceutical composition comprising adalimumab

Country Status (5)

Country Link
EP (1) EP3085385B1 (en)
CN (1) CN104707146B (en)
MX (1) MX2016007878A (en)
RU (1) RU2664736C2 (en)
WO (1) WO2015090162A1 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
EP3050557A1 (en) 2014-05-23 2016-08-03 Ares Trading S.A. Liquid pharmaceutical composition
ES2607489T3 (en) 2014-05-23 2017-03-31 Ares Trading S.A. Liquid pharmaceutical composition
CN106620691B (en) * 2015-11-04 2020-08-21 信达生物制药(苏州)有限公司 Recombinant fully human anti-CTLA-4 monoclonal antibody preparation and application thereof
CN106955361B (en) * 2016-01-08 2020-10-27 浙江海正药业股份有限公司 A pharmaceutical composition containing CE as tuberculosis allergen
RU2736830C2 (en) * 2016-01-12 2020-11-20 Др. Редди'С Лабораторис Лимитед Stable pharmaceutical composition
CR20180599A (en) 2016-06-30 2019-04-09 Celltrion Inc STABLE LIQUID PHARMACEUTICAL PREPARATION
MA47106A (en) * 2016-12-21 2019-10-30 Amgen Inc ANTI-TNF ALPHA ANTIBODY FORMULATIONS
RU2764521C2 (en) * 2017-12-29 2022-01-18 Закрытое Акционерное Общество "Биокад" AQUEOUS PHARMACEUTICAL COMPOSITION OF A RECOMBINANT MONOCLONAL ANTIBODY TO TNF-α
CA3049857A1 (en) 2017-01-11 2018-07-19 Celltrion Inc. Stable liquid formulation
CN106913869B (en) * 2017-03-17 2020-07-28 信达生物制药(苏州)有限公司 anti-CT L A-4 monoclonal antibody preparation and application thereof
CN108686204A (en) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 Include the infliximab composition of histidine buffer system
CN108686205B (en) * 2017-04-07 2021-12-10 海正生物制药有限公司 Lyophilized preparation of infliximab
CN111665352B (en) * 2020-06-23 2024-05-17 广州市丹蓝生物科技有限公司 Storage agent, antibody solution preparation prepared from storage agent and application of storage agent

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009073569A2 (en) * 2007-11-30 2009-06-11 Abbott Laboratories Protein formulations and methods of making same
WO2010129469A1 (en) * 2009-05-04 2010-11-11 Abbott Biotechnology Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
WO2011104381A2 (en) * 2010-02-26 2011-09-01 Novo Nordisk A/S Stable antibody containing compositions
EP2363145A1 (en) * 2002-08-16 2011-09-07 Abbott Biotechnology Ltd Pharmaceutical anti-TNF-alpha antibody formulation

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ZA966075B (en) * 1995-07-27 1998-01-19 Genentech Inc Protein formulation.
DK2275119T3 (en) * 1995-07-27 2013-11-11 Genentech Inc Stable, isotonic lyophilized protein formulation
AU2007229554A1 (en) * 2006-03-28 2007-10-04 F. Hoffmann-La Roche Ag Anti-IGF-1R human monoclonal antibody formulation
KR20100120289A (en) * 2008-01-15 2010-11-15 애보트 게엠베하 운트 콤파니 카게 Powdered protein compositions and methods of making same
WO2011163458A2 (en) * 2010-06-24 2011-12-29 Genentech, Inc. Compositions and methods for stabilizing protein-containing formulations
SG10201609982PA (en) * 2012-03-07 2017-01-27 Cadila Healthcare Ltd Pharmaceutical formulations of tnf-alpha anitbodies

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2363145A1 (en) * 2002-08-16 2011-09-07 Abbott Biotechnology Ltd Pharmaceutical anti-TNF-alpha antibody formulation
WO2009073569A2 (en) * 2007-11-30 2009-06-11 Abbott Laboratories Protein formulations and methods of making same
WO2010129469A1 (en) * 2009-05-04 2010-11-11 Abbott Biotechnology Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
WO2011104381A2 (en) * 2010-02-26 2011-09-01 Novo Nordisk A/S Stable antibody containing compositions

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2015090162A1 *

Also Published As

Publication number Publication date
EP3085385A1 (en) 2016-10-26
WO2015090162A1 (en) 2015-06-25
CN104707146A (en) 2015-06-17
EP3085385B1 (en) 2021-08-25
MX2016007878A (en) 2016-10-21
RU2664736C2 (en) 2018-08-22
CN104707146B (en) 2019-04-16
RU2016125159A (en) 2018-01-23

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